Medicare Part D. What Pharmacists Need to Know to Navigate Through 2006 and Beyond

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Medicare Part D What Pharmacists Need to Know to Navigate Through 2006 and Beyond February 23, 2006

Medicare Part D What Pharmacists Need to Know to Navigate Through 2006 and Beyond Introduction The program this evening will help pharmacists better understand the complexities of Medicare Part D implementation. This activity will also provide pharmacists the opportunity to gain valuable insight and additional knowledge to help them and their patients navigate Medicare Part B and D. There is no charge for this event. Agenda Registration: 6:30 PM Dinner Served: 7:00 PM Medicare Part D Presentation: 7:30-8:30 PM Question and Answer Session: 8:30-9:00 PM Faculty Special guest speaker Steven Stranne, M.D., J.D. is a partner in the Washington, D.C. office of the law firm Powell Goldstein LLP, and is also an active member of an affiliated health policy research group, HealthPolicy R&D. He received his M.D. from Duke University School of Medicine and his J.D. from Harvard Law School. Learning Objectives Upon successful completion, participants will be able to: Discuss how the complexities of the new Medicare Part D Prescription Drug Program are impacting pharmacy practitioners in Kansas, Missouri, and throughout the United States. Assist patients in selecting optimal Part D plan(s) to ensure they are receiving full access to their benefits. Address concerns relating to the limitations that Medicare s rules place on pharmacists and other providers with respect to counseling patients. Describe specific solutions to access problems being experienced across the nation, particularly as this relates to low-income beneficiaries. State which medications are payable under Medicare Part D versus Part B.

Faculty Disclosure RxSchool has a Full and Fair Disclosure Policy that requires course faculty to communicate any real or apparent commercial affiliations related to the content of their presentations/ materials. Dr. Stranne has no conflicts of interest to disclose. Accreditation & Designation This program is approved for 1.5 hours of pharmacy continuing education credit by RxSchool. Upon completion of this activity, participants will be directed to login to www.rxschool.com to complete the program evaluation questionnaire and obtain their CE Statement of Credit. To Obtain Your Statement of Live CE Credit.. 3.. 5. 6. Go to www.rxschool.com. Click the Log In link on the top left of the page (or click Register, if you are not yet a registered user). Log in to the system using your current username and password. Click the Catalog link in the top menu and select Live CE in the sub-menu. In the list onscreen, click the name of the course or conference you attended. If you do not see it in the list, type the title or topic into the Search Listings field and click Search, or click on the calendar icon to select the date of the event. Follow the onscreen instructions to select the session(s) you attended, complete the online evaluation, and print your statement of credit. You will be prompted to enter the live CE code that was given to you at the conclusion of the event. Commercial Support This activity has been supported through an educational grant from TEVA Neuroscience, Inc. RxSchool is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE #: 372-000-06-001-L04 For information regarding this CE activity, please contact Bill Boles at 720-206-1199.

Medicare Part D What Pharmacists Need to Know to Navigate Through 2006 and Beyond Presented on behalf of: RxSchool Steven K. Stranne, M.D., J.D. Powell Goldstein LLP Kansas City, Missouri February 23, 2006 Objectives 1. Discuss the complexities of Medicare Part D relevant to pharmacy practitioners in Kansas and Missouri 2. Describe how best to assist patients with plan selection 3. Determine limits on what can say when counseling on plan selection 2 Objectives (continued) 4. Discuss Part D access problems and solutions in Kansas and Missouri, particularly for low- income patients 5. Contrast and compare Part D versus Part B distinctions that are relevant to your everyday operations 6. To address your questions 3 3

Overview Benefit began January 1, 2006 Beneficiary frustration and confusion regarding plan selection Initial logistics problems Concerns about low beneficiary enrollment Are these short-term issues or long-term problems? 4 Overview Long-awaited comprehensive prescription drug benefit Largest change in Medicare since its inception Differs significantly from drug coverage under Medicare Part B 5 Modeled After Private Sector Private entities compete To win contracts and attract enrollees To negotiate rates for drugs and pharmacy services More like private sector drug benefits Formularies and tiered co-pays Prior authorization and step-therapy requirements 6

Objective 1 Discuss the complexities of Medicare Part D relevant to pharmacy practitioners in Kansas and Missouri 7 Beneficiary Eligibility and Enrollment Medicare Part D open to Medicare beneficiaries eligible for Parts A or B Voluntary enrollment Dual-eligible beneficiaries Have been auto-assigned into plans But they may select new plans monthly Initial enrollment began November 15, 2005, but continues until May 15, 2006 8 Two Types of Plans Available Prescription drug plans (PDPs) provide standalone prescription drug coverage Medicare Advantage-Prescription Drug (MA- PD) plans provide Part D coverage coupled to Medicare s managed care benefit 9 5

Kansas and Missouri 40 stand-alone plans available in each of these states, as well as many more MA-PD plans Kansas Part D premiums range from $9.48 to $67.88 per month Missouri Part D premiums range from $10.29 to $68.26 per month 10 The Standard Medicare Prescription Drug Benefit Stop-loss $5,100 incurred drug expenditures ($3,600 in beneficiary out-of-pocket expenses) Initial coverage limit $2,250 Average National Monthly Premium = $32.30 (lower?) Catastrophic: Coverage CMS + health Insurer plan Pays pay 90% 95% of Costs Doughnut Hole Beneficiary Pays 100% ($2,850) 75% Paid by 50% of Costs Plan Paid by Insurer ($1,500) ($2,113) 5% Cost-sharing for beneficiaries above stop-loss threshold Beneficiary Paid Insurer Paid 25% Coinsurance paid by beneficiary ($500) $250 Deductible 11 Variability Significant variability in structure and premiums among standard plans Enhanced plans provide even more variation Offer one or more alternative benefit packages Extra cost to beneficiary associated with these benefits Variability has resulted in confusion and frustration among beneficiaries 12 6

Drugs Coverable Under Part D Those drugs regulated by FDA as drugs Wrap-around principle Those drugs not already coverable under Parts A or B As administered Some drugs explicitly excluded from coverage (e.g., hair loss, weight loss) Coverage includes smoking cessation drugs, insulin and related supplies 13 Access to Prescription Drugs Can Differ from One Plan to Another Sponsors establish their own benefit plans Formularies Tiered co-payments Prior authorization requirements So even if coverable under Part D Issue remains whether placed on a plan s formulary Whether a favorable co-pay 14 Added Complexity: Out-of-Network Claims Pharmacies bill the beneficiary directly, even if dual eligible or low-income Beneficiaries responsible for difference between plan allowance and pharmacy charge (counts as TrOOP) No CMS requirements, but helpful to include name of drug, quantity, amount paid and NDC number 15 7

Objective 2 Describe how best to assist patients with plan selection 16 Medicare Part D: Implementation Timeline Anticipate ongoing questions from patients Enrollment for 2006 ends May 15, 2006 Beneficiaries become newly-eligible for Medicare throughout the year Enrollment for 2007 begins November 15, 2006 17 Whether or Not to Sign Up Is Part D better than nothing? Consider that patients can buy drugs at discounted rates within the doughnut hole Receive catastrophic coverage Is it better than retiree coverage or other alternatives that an individual patient may have? 18 8

Late Enrollment Penalty Applies when a beneficiary goes more than 63 days without creditable coverage Equals 1% of the national average monthly premium (established annually by CMS) for each full month of non-coverage Cumulative effect: 7 month delay results in a penalty of about $2 monthly thereafter? Penalty continues in place so long as the beneficiary remains enrolled in Part D 19 Pharmacy Selection Many seniors have established relationships with local pharmacies and pharmacists Patient co-pays will be lowest for in-network pharmacies, preferred pharmacies Snow birds may benefit from pharmacy networks that cover other parts of the country 20 Selecting the Best Plan CMS reviews each formulary To guard against policies that discriminate against patients with certain diseases, high costs Comparing to industry best practices (other formularies) and national treatment guidelines 21 9

CMS Formulary Safeguards Generally, at least 2 drugs per category In some cases, CMS is requiring coverage of all/substantially all drugs in a category Antidepressants, anti-psychotics, anti-convulsants, anticancer, anti-retrovirals and immunosuppressants USP Model Formulary 22 Current Drug Regimens Patients can compare coverage and costs for current drug regimens under various plans Calling 1-800-Medicare Use web at www.medicare.gov (Medicare Drug Finder Tool) Patients should ask questions if their drugs appear to require prior authorization or step-therapy 23 Purpose of Insurance Keep in mind that insurance exists to protect against future health needs that may or may not be anticipated Consider whether the beneficiary is likely to stick with their initial plan selection over the years These considerations may help diminish pressure to select the single best plan for current drug regimen 24 10

Objective 3 Determine the limits on what you can say when counseling on plan selection 25 Tension Exists CMS wants pharmacists and other providers to help provide guidance to beneficiaries CMS prohibits providers from making specific plan recommendations Providers may not steer undecided enrollees to a particular plan or limited number of plans Providers may not accept applications for a plan 26 Medicare Marketing Guidelines Marketing guidelines apply to pharmacists, physicians and other providers contracting with the Plan Such providers may not rank order or highlight any of the plans they discuss Providers may not advocate for any particular group or plan Providers may not accept applications 27 11

Providers May Distribute and/or make available plan marketing material Provide patients with information about different plans benefits Educate patients on what kind(s) of plan(s) would be best for them 28 Providers Also May Allow presentations by plan representatives in their places of business Must ensure that the presentation is in a common area with open access to anyone who wants to attend Must ensure the presentation does not take place anywhere health care services are provided 29 Provider Marketing Guidelines Provider s may provide comparative and descriptive plan information, subject to the following: Materials may not rank order or highlight specific Plans Only include objective information Must have concurrence of all Plans involved in the comparison Must be approved by CMS prior to distribution Plans may NOT use providers to distribute comparative information UNLESS providers accept and display materials from all plans in the service area that contract with the provider. 30 12

Provider Marketing Guidelines Provider web sites May provide links to Plan enrollment applications and/or provide downloadable enrollment applications Site must provide the links/downloadable formats to enrollment applications for ALL plans with which the provider participates May link to CMS Online Enrollment Center 31 Additional Guidance on Controlling Fraud and Abuse Prescription Drug Benefit Manual published by CMS on on February 8 Targeted to health plans, but important for pharmacies to include within compliance efforts Comments can be submitted to CMS until March 1st 1st 32 Objective 4 Discuss Part D access problems and solutions in Kansas and Missouri, particularly for lowincome patients income patients 33 13

Initial Implementation Crisis Mostly involves dual eligible patients Problems throughout Kansas, Missouri and nation Enrollment verification problems Overcharges to beneficiaries Enrolled in plans in wrong state Kansas and Missouri making emergency payments to ensure access CMS directives to plans (90 day supply, etc.) 34 Subsidies under Medicare Part D Subsidies for individuals eligible for both Medicare and Medicaid (Dual-Eligibles) Subsidies for other low-income beneficiaries 35 Dual-Eligibles Medicare will assume financial responsibility for drugs for beneficiaries dually- eligible for Medicare and Medicaid Auto-enrollment occurred in a Part D plan if beneficiary didn t elect a plan No deductible, no premium, no cost-sharing and minimal co-payments no coverage gap (doughnut hole) 36 14

Other Low-Income Individuals Similar full subsidy for income below 135% FPL Partial subsidy for individuals with income between 135% and 150% FPL Low deductible ($50), sliding scale premium, 15% copayment up to out-of-pocket limit ($3,600) and no coverage gap/doughnut hole 37 Beneficiary Assistance Programs Counts Toward TrOOP Costs State pharmaceutical assistance programs (SPAPs) Kansas Missouri Financial assistance provided by charities Financial assistance from family members 38 However, Other Drug Coverage Third-party insurance coverage does not count toward TrOOP, including: Employer and union-sponsored coverage Commercial supplemental coverage policies 39 15

Pharmaceutical Manufacturers Compassionate Use Programs CMS said could count toward TrOOP But November 2005 advisory from HHS OIG has required manufacturers to revisit the structure of their programs Be aware of changes in early 2006 40 Objective 5 Compare and Contrast Medicare Part D versus Part B distinctions that are relevant to your everyday operations 41 Medicare Part B: Existing Drug Coverage Will Remain Unchanged New drugs will be added to Part B in the future, if fall in longstanding Part B coverage rules Incident to a physicians services ( self-administered definition remains relevant) Covered under the home DME benefit Inhalation drug therapy Infusion drug therapy Covered by statute Oral cancer and anti-emetic drugs Immunosuppressive drugs for transplant patients under some circumstances 42 16

Interaction of Medicare Parts B and D Part D benefit intended to wrap around drug coverage provided under Parts A & B Some drugs may be: Covered under Part B in certain circumstances But covered under Part D in other circumstances Examples include immunosuppressive drugs for transplant patients and infusion drugs 43 Claims Submission Issues Should not have to bill Part B merely for denial Understand the rules for drugs that may be covered under either Part B or Part D Submit claim as appropriate Resources 44 Patient Costs under Part B and D Costs paid by patients differ significantly under Part B and Part D 20% under Part B 25% under Part D, 100% under the doughnut hole, 5% under catastrophic But low-income patients have more generous Part D benefit 45 17

Home Infusion Drug Therapy Some home infusion drug therapies are covered under Part B already The remainder of home infusion drugs will be covered under Medicare Part D No coverage currently exists for some of the professional services and all of the supplies and equipment necessary for home infusion Policymakers still working on how to address 46 Objective 6 To address your questions 47 Concluding Observations Predictable logistics problems are ongoing during start- up period Predict ongoing questions on plan selection through May, ongoing for newly-eligible, and again in fall during open enrollment for 2007 Expect refinements and changes to the benefit over the upcoming months and years Political implications remain uncertain 48 18

Steven K. Stranne, M.D., J.D. 202.624.7301 SStranne@pogolaw.com 19

2601 Blake Street, Suite 400 Denver, Colorado 80205 www.rxschool.com Bill Boles 720-206-1199 bboles@rxschool.com